Thursday, 29 September 2016

dipyridamole Oral, Intravenous


dye-pir-ID-a-mole


Commonly used brand name(s)

In the U.S.


  • Persantine

Available Dosage Forms:


  • Tablet

  • Capsule, Extended Release

  • Solution

  • Tablet, Extended Release

Therapeutic Class: Platelet Aggregation Inhibitor


Pharmacologic Class: Phosphodiesterase Inhibitor


Uses For dipyridamole


Dipyridamole is used to lessen the chance of stroke or other serious medical problems that may occur when a blood vessel is blocked by blood clots. It is given only when there is a larger-than-usual chance that these problems may occur. For example, it is given to people who have had diseased heart valves replaced by mechanical valves, because dangerous blood clots are especially likely to occur in these patients. Dipyridamole works by helping to prevent dangerous blood clots from forming.


Dipyridamole may also be used for other heart and blood conditions as determined by your doctor.


Dipyridamole is also sometimes used as part of a medical test that shows how well blood is flowing to your heart. For information on this use of dipyridamole, see Dipyridamole—Diagnostic (Systemic).


Dipyridamole is available only with your doctor's prescription.


Before Using dipyridamole


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For dipyridamole, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to dipyridamole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


dipyridamole has been tested only in adults and in children older than 12 years of age. There is no specific information comparing use of dipyridamole in children younger than 12 years of age with use in other age groups.


Geriatric


Dipyridamole has not been studied specifically in older people taking the medicine regularly to prevent blood clots from forming. Although there is no specific information comparing this use of dipyridamole in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking dipyridamole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using dipyridamole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acenocoumarol

  • Alteplase, Recombinant

  • Argatroban

  • Bivalirudin

  • Bromfenac

  • Celecoxib

  • Cilostazol

  • Citalopram

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Desvenlafaxine

  • Diclofenac

  • Diflunisal

  • Drotrecogin Alfa

  • Duloxetine

  • Enoxaparin

  • Escitalopram

  • Etodolac

  • Fluoxetine

  • Flurbiprofen

  • Fluvoxamine

  • Fondaparinux

  • Heparin

  • Ibuprofen

  • Ibuprofen Lysine

  • Indomethacin

  • Ketoprofen

  • Ketorolac

  • Lepirudin

  • Magnesium Salicylate

  • Mefenamic Acid

  • Meloxicam

  • Milnacipran

  • Nabumetone

  • Naproxen

  • Nefazodone

  • Nepafenac

  • Oxaprozin

  • Paroxetine

  • Phenindione

  • Phenprocoumon

  • Piroxicam

  • Protein C, Human

  • Rivaroxaban

  • Salsalate

  • Sertraline

  • Streptokinase

  • Sulindac

  • Tinzaparin

  • Tolmetin

  • Venlafaxine

  • Warfarin

Using dipyridamole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adenosine

  • Indomethacin

  • Tenecteplase

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of dipyridamole. Make sure you tell your doctor if you have any other medical problems, especially:


  • Chest pain—The chance of side effects may be increased

  • Low blood pressure—Large amounts of dipyridamole can make your condition worse

Proper Use of dipyridamole


dipyridamole works best when there is a constant amount in the blood. To help keep the amount constant, dipyridamole must be taken in regularly spaced doses, as ordered by your doctor.


dipyridamole works best when taken with a full glass (8 ounces) of water at least 1 hour before or 2 hours after meals. However, to lessen stomach upset, your doctor may want you to take the medicine with food or milk.


Dosing


The dose of dipyridamole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dipyridamole. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For preventing blood clots:
    • For oral dosage form (tablets):
      • Adults—The usual dose is 75 to 100 milligrams (mg) four times a day taken together with an anticoagulant (blood-thinning) medicine.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of dipyridamole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using dipyridamole


Dipyridamole is sometimes used together with an anticoagulant (blood thinner) or aspirin. The combination of medicines may provide better protection against the formation of blood clots than any of the medicines used alone. However, the risk of bleeding may also be increased when dipyridamole is taken with aspirin. To reduce the risk of bleeding:


  • Do not take aspirin, or any combination medicine containing aspirin, unless the same doctor who directed you to take dipyridamole also directs you to take aspirin. This is especially important if you are taking an anticoagulant together with dipyridamole.

  • If you have been directed to take aspirin together with dipyridamole, take only the amount of aspirin ordered by your doctor . If you need a medicine to relieve pain or a fever, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so that you will know ahead of time what medicine to take.

  • Your doctor should check your progress at regular visits.

Tell all medical doctors and dentists you go to that you are taking dipyridamole, and whether or not you are taking an anticoagulant (blood thinner) or aspirin together with it.


Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.


dipyridamole Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Rare
  • Chest pain

  • gallstones

  • tightness or swelling of neck

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abdominal or stomach cramps

  • diarrhea

  • dizziness or lightheadedness

Less common
  • Flushing

  • headache

  • nausea or vomiting

  • weakness

Rare
  • General discomfort and/or unusual tiredness or weakness

  • hair loss

  • joint pain or swelling

  • muscle pain

  • runny nose

  • sneezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: dipyridamole Oral, Intravenous side effects (in more detail)



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More dipyridamole Oral, Intravenous resources


  • Dipyridamole Oral, Intravenous Side Effects (in more detail)
  • Dipyridamole Oral, Intravenous Use in Pregnancy & Breastfeeding
  • Drug Images
  • Dipyridamole Oral, Intravenous Drug Interactions
  • Dipyridamole Oral, Intravenous Support Group
  • 0 Reviews for Dipyridamole Oral, Intravenous - Add your own review/rating


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Tuesday, 27 September 2016

Desloratadine/Pseudoephedrine Sustained-Release Tablets


Pronunciation: DES-lor-A-ta-deen/SOO-doe-e-FED-rin
Generic Name: Desloratadine/Pseudoephedrine
Brand Name: Examples include Clarinex-D 12 Hour and Clarinex-D 24 Hour


Desloratadine/Pseudoephedrine Sustained-Release Tablets are used for:

Temporarily relieving symptoms of hay fever or respiratory allergies, such as stuffy or runny nose, sneezing, itchy or watery eyes, itchy nose or throat, or sinus congestion or pressure. It may also be used for other conditions as determined by your doctor.


Desloratadine/Pseudoephedrine Sustained-Release Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.


Do NOT use Desloratadine/Pseudoephedrine Sustained-Release Tablets if:


  • you are allergic to any ingredient in Desloratadine/Pseudoephedrine Sustained-Release Tablets or to similar medicines (eg, loratadine)

  • you have narrow-angle glaucoma, severe high blood pressure, a rapid heartbeat, severe heart problems, severe heart/blood vessel disease (coronary artery disease), or severe difficulty urinating

  • you are taking droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

  • you have experienced serious side effects such as irregular heart rhythms with decongestants (eg, pseudoephedrine, phenylephrine)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Desloratadine/Pseudoephedrine Sustained-Release Tablets:


Some medical conditions may interact with Desloratadine/Pseudoephedrine Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of high blood pressure, heart or blood vessel problems, diabetes, kidney or liver problems, glaucoma, seizures, stroke, adrenal gland problems, an enlarged prostate or other prostate problems, trouble sleeping, or an overactive thyroid

Some MEDICINES MAY INTERACT with Desloratadine/Pseudoephedrine Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Furazolidone or MAOIs (eg, phenelzine) because side effects, such as headache, fever, and severe high blood pressure, may occur

  • Digoxin or droxidopa because irregular heartbeat or heart attack may occur

  • Beta-blockers (eg, propranolol), guanadrel, guanethidine, methyldopa, or reserpine because their effectiveness may be decreased by Desloratadine/Pseudoephedrine Sustained-Release Tablets

  • Bromocriptine because its side effects or toxic effects may be increased by Desloratadine/Pseudoephedrine Sustained-Release Tablets

  • Urinary alkalinizers (eg, sodium bicarbonate) because they may increase the actions and the risk of Desloratadine/Pseudoephedrine Sustained-Release Tablets's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Desloratadine/Pseudoephedrine Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Desloratadine/Pseudoephedrine Sustained-Release Tablets:


Use Desloratadine/Pseudoephedrine Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Desloratadine/Pseudoephedrine Sustained-Release Tablets. Talk to your pharmacist if you have questions about this information.

  • Take Desloratadine/Pseudoephedrine Sustained-Release Tablets by mouth with or without food.

  • Swallow Desloratadine/Pseudoephedrine Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.

  • If you miss a dose of Desloratadine/Pseudoephedrine Sustained-Release Tablets and are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Desloratadine/Pseudoephedrine Sustained-Release Tablets.



Important safety information:


  • Desloratadine/Pseudoephedrine Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Desloratadine/Pseudoephedrine Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better within 7 days, or if they get worse, check with your doctor.

  • Desloratadine/Pseudoephedrine Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Before you begin taking any new medicines, either prescription or nonprescription, check with your doctor or pharmacist. This includes any medicines that contain appetite suppressants, antihistamines, or decongestants.

  • Desloratadine/Pseudoephedrine Sustained-Release Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Desloratadine/Pseudoephedrine Sustained-Release Tablets for a few days before the tests.

  • Use Desloratadine/Pseudoephedrine Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

  • Desloratadine/Pseudoephedrine Sustained-Release Tablets should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Desloratadine/Pseudoephedrine Sustained-Release Tablets while you are pregnant. Desloratadine/Pseudoephedrine Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Desloratadine/Pseudoephedrine Sustained-Release Tablets.


Possible side effects of Desloratadine/Pseudoephedrine Sustained-Release Tablets:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Coughing; dizziness; drowsiness; dry mouth; excitability; fatigue; headache; loss of appetite; mild stomach upset; nausea; nervousness; sleeplessness; sore throat; thirst; tiredness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fast/irregular heartbeat; mental/mood changes (eg, anxiety, delusions, hallucinations); seizures; severe dizziness; shortness of breath; uncontrolled shaking or tremor.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Desloratadine/Pseudoephedrine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include high fever; fast, slow, or irregular heartbeat; loss of consciousness; mental or mood changes (eg, hallucinations); seizures; severe drowsiness or dizziness; trouble breathing; unusual nervousness or excitement.


Proper storage of Desloratadine/Pseudoephedrine Sustained-Release Tablets:

Store Desloratadine/Pseudoephedrine Sustained-Release Tablets at 77 degrees F (25 degrees C). Avoid exposure to temperatures above 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Desloratadine/Pseudoephedrine Sustained-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Desloratadine/Pseudoephedrine Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Desloratadine/Pseudoephedrine Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Desloratadine/Pseudoephedrine Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Desloratadine/Pseudoephedrine resources


  • Desloratadine/Pseudoephedrine Side Effects (in more detail)
  • Desloratadine/Pseudoephedrine Use in Pregnancy & Breastfeeding
  • Desloratadine/Pseudoephedrine Drug Interactions
  • Desloratadine/Pseudoephedrine Support Group
  • 1 Review for Desloratadine/Pseudoephedrine - Add your own review/rating


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  • Hay Fever

Tolterodine Extended-Release Capsules


Pronunciation: tol-TER-oh-deen
Generic Name: Tolterodine
Brand Name: Detrol LA


Tolterodine Extended-Release Capsules are used for:

Treating overactive bladder with symptoms of urinary frequency, urgency, and leakage. It may also be used for other conditions as determined by your doctor.


Tolterodine Extended-Release Capsules are an antimuscarinic (anticholinergic) agent. It works by blocking a chemical that causes contractions of the bladder.


Do NOT use Tolterodine Extended-Release Capsules if:


  • you are allergic to any ingredient in Tolterodine Extended-Release Capsules or to fesoterodine

  • you have uncontrolled narrow-angle glaucoma, trouble urinating, or have slowed emptying of your stomach

  • you are taking a solid oral potassium product (eg, tablet)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Tolterodine Extended-Release Capsules:


Some medical conditions may interact with Tolterodine Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have glaucoma; a blockage of the bladder, stomach, or bowel; stomach or bowel problems (eg, slowed moving of the bowels, constipation); spinal cord injury; dementia; liver or kidney problems; or myasthenia gravis (muscle weakness)

  • if you or a family member have a history of irregular heartbeat (eg, prolonged QT, long QT syndrome)

Some MEDICINES MAY INTERACT with Tolterodine Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Antiarrhythmics (eg, amiodarone, quinidine) because the risk of irregular heartbeat may be increased

  • Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by Tolterodine Extended-Release Capsules

  • Other anticholinergics (eg, scopolamine), azole antifungals (eg, itraconazole, ketoconazole, miconazole), cyclosporine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, or vinblastine because they may increase the risk of Tolterodine Extended-Release Capsules's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tolterodine Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Tolterodine Extended-Release Capsules:


Use Tolterodine Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Tolterodine Extended-Release Capsules. Talk to your pharmacist if you have questions about this information.

  • Take Tolterodine Extended-Release Capsules by mouth with or without food.

  • Swallow Tolterodine Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • Tolterodine Extended-Release Capsules works best if it is taken at the same time each day.

  • If you miss a dose of Tolterodine Extended-Release Capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tolterodine Extended-Release Capsules.



Important safety information:


  • Tolterodine Extended-Release Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tolterodine Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do NOT change your dose of Tolterodine Extended-Release Capsules without checking with your doctor.

  • Tolterodine Extended-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • Caution is advised when using Tolterodine Extended-Release Capsules in CHILDREN; they may be more sensitive to its effects, especially an increased risk for urinary tract infection and behavior or attention problems.

  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tolterodine Extended-Release Capsules while you are pregnant. It is not known if Tolterodine Extended-Release Capsules are found in breast milk. Do not breast-feed while taking Tolterodine Extended-Release Capsules.


Possible side effects of Tolterodine Extended-Release Capsules:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Blurred vision; constipation; dizziness; drowsiness; dry eyes; dry mouth; headache; indigestion; stomach pain.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; confusion, disorientation, or memory problems; difficult or painful urination; fast or irregular heartbeat; fainting; hallucinations; severe dizziness; swelling of the hands, ankles, or feet.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Tolterodine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficulty breathing; difficulty urinating; dilated pupils; dry mouth; excitation; fast heartbeat; hallucinations; seizures.


Proper storage of Tolterodine Extended-Release Capsules:

Store Tolterodine Extended-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tolterodine Extended-Release Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Tolterodine Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Tolterodine Extended-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tolterodine Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tolterodine resources


  • Tolterodine Side Effects (in more detail)
  • Tolterodine Dosage
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  • Tolterodine Drug Interactions
  • Tolterodine Support Group
  • 19 Reviews for Tolterodine - Add your own review/rating


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diphenhydramine, hydrocodone, and phenylephrine


Generic Name: diphenhydramine, hydrocodone, and phenylephrine (dye fen HYE dra meen, hye droe KOE dohn, feh nill EH frin)

Brand names: Endal HD, Tussinate, Hydro-DP, Rindal HPD, Gestuss-HC, Dytan-HC, D-Tann HC


What is diphenhydramine, hydrocodone, and phenylephrine?

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body and reduces congestion.


Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.


Phenylephrine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in the body. Constriction of blood vessels in the sinuses and nose decreases congestion.


Diphenhydramine, hydrocodone, and phenylephrine is used to treat cough and nasal congestion associated with upper respiratory tract infections and allergies.


Diphenhydramine, hydrocodone, and phenylephrine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about diphenhydramine, hydrocodone, and phenylephrine?


Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine, hydrocodone, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine, hydrocodone, and phenylephrine.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.


Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if diphenhydramine, hydrocodone, and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

What should I discuss with my healthcare provider before taking diphenhydramine, hydrocodone, and phenylephrine?


Do not take diphenhydramine, hydrocodone, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.


Before taking diphenhydramine, hydrocodone, and phenylephrine, tell your doctor if you have



  • epilepsy or another seizure disorder;




  • been diagnosed with sleep apnea (periods of not breathing during sleep);




  • thyroid problems;




  • asthma;




  • gallbladder disease;




  • a head injury;




  • Addison's disease;




  • diabetes;




  • glaucoma;




  • an ulcer or an obstruction in the stomach;




  • bladder problems or difficulty urinating;



  • an enlarged prostate;


  • high blood pressure, irregular heartbeats, or any type of heart disease;



  • kidney problems; or

  • liver problems.

You may not be able to take diphenhydramine, hydrocodone, and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Diphenhydramine, hydrocodone, and phenylephrine is in the FDA pregnancy category C. This means that it is not known whether diphenhydramine, hydrocodone, and phenylephrine will be harmful to an unborn baby. Do not take diphenhydramine, hydrocodone, and phenylephrine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether diphenhydramine, hydrocodone, and phenylephrine passes into breast milk. Do not take diphenhydramine, hydrocodone, and phenylephrine without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine, hydrocodone, and phenylephrine. Your doctor may prescribe a lower dose of this medication.

How should I take diphenhydramine, hydrocodone, and phenylephrine?


Take diphenhydramine, hydrocodone, and phenylephrine exactly as directed by your doctor. If you do not understand the directions on your prescription bottle, ask your pharmacist, nurse, or doctor to explain the instructions to you.


Diphenhydramine, hydrocodone, and phenylephrine can be taken with or without food.


To ensure that you get a correct dose, measure the liquid form of diphenhydramine, hydrocodone, and phenylephrine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Store diphenhydramine, hydrocodone, and phenylephrine at room temperature away from moisture and heat.

See also: Diphenhydramine, hydrocodone, and phenylephrine dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine, hydrocodone, and phenylephrine overdose may include severe drowsiness, dizziness, headache, seizures, dry mouth, cold and clammy skin, flushing, nausea, vomiting, difficulty or decreased breathing, and unconsciousness.


What should I avoid while taking diphenhydramine, hydrocodone, and phenylephrine?


Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine, hydrocodone, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine, hydrocodone, and phenylephrine.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.


Diphenhydramine, hydrocodone, and phenylephrine side effects


If you experience any of the following serious side effects, stop taking diphenhydramine, hydrocodone, and phenylephrine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or




  • confusion, hallucinations, or unusual behavior.



Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine, hydrocodone, and phenylephrine and talk to your doctor if you experience



  • dizziness, drowsiness, or sleepiness;




  • restlessness or irritability;




  • blurred vision;




  • constipation;




  • dry mouth, nausea, vomiting, or decreased appetite;




  • muscle twitches;




  • sweating;




  • itching;




  • decreased urination;




  • increased sensitivity to sunlight.




Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if diphenhydramine, hydrocodone, and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Diphenhydramine, hydrocodone, and phenylephrine Dosing Information


Usual Adult Dose for Cough and Nasal Congestion:

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-2 mg-7.5 mg/5 mL:
10 mL orally every 4 hours not to exceed 40 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-3.5 mg-5 mg/5 mL:
10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 25 mg-3.5 mg-7.5 mg/5 mL:
5 mL to 10 mL orally every 12 hours.

Usual Pediatric Dose for Cough and Nasal Congestion:

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-2 mg-7.5 mg/5 mL:
>12 yrs: 10 mL orally every 4 hours not to exceed 40 mL daily.
6 yrs to >=12 yrs: 5 mL orally every 4 hours not to exceed 20 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-3.5 mg-5 mg/5 mL:
>12 yrs: 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.
6 yrs to >=12 yrs: 5 mL orally every 4 to 6 hours not to exceed 20 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 25 mg-3.5 mg-7.5 mg/5 mL:
>12 yrs: 5 mL to 10 mL orally every 12 hours
6 yrs to >=12 yrs: 2.5 mL to 5 mL orally every 12 hours


What other drugs will affect diphenhydramine, hydrocodone, and phenylephrine?


Do not take diphenhydramine, hydrocodone, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.


Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.


Drugs other than those listed here may also interact with diphenhydramine, hydrocodone, and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More diphenhydramine, hydrocodone, and phenylephrine resources


  • Diphenhydramine, hydrocodone, and phenylephrine Side Effects (in more detail)
  • Diphenhydramine, hydrocodone, and phenylephrine Dosage
  • Diphenhydramine, hydrocodone, and phenylephrine Use in Pregnancy & Breastfeeding
  • Diphenhydramine, hydrocodone, and phenylephrine Drug Interactions
  • Diphenhydramine, hydrocodone, and phenylephrine Support Group
  • 0 Reviews for Diphenhydramine, hydrocodone, and phenylephrine - Add your own review/rating


Compare diphenhydramine, hydrocodone, and phenylephrine with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist has more information about diphenhydramine, hydrocodone, and phenylephrine written for health professionals that you may read.

See also: diphenhydramine, hydrocodone, and phenylephrine side effects (in more detail)


Friday, 23 September 2016

Bekanamycine




Bekanamycine may be available in the countries listed below.


Ingredient matches for Bekanamycine



Bekanamycin

Bekanamycine (DCIT) is also known as Bekanamycin (Rec.INN)

International Drug Name Search

Glossary

DCITDenominazione Comune Italiana
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Thursday, 22 September 2016

irbesartan


ir-be-SAR-tan


Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .



Commonly used brand name(s)

In the U.S.


  • Avapro

Available Dosage Forms:


  • Tablet

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Angiotensin II Receptor Antagonist


Uses For irbesartan


Irbesartan belongs to the class of medicines called angiotensin II inhibitor antihypertensives. It is used to treat high blood pressure (hypertension).


High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Irbesartan works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, irbesartan relaxes blood vessels. This lowers blood pressure.


irbesartan is available only with your doctor's prescription.


Before Using irbesartan


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For irbesartan, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to irbesartan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


irbesartan has been tested in children over 6 years of age and has not been shown to cause different side effects or problems than it does in adults.


Geriatric


irbesartan has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, blood levels of irbesartan may be increased in the elderly and elderly patients may be more sensitive to the effects of irbesartan.


Pregnancy














Pregnancy CategoryExplanation
1st TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking irbesartan, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using irbesartan with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Bromfenac

  • Celecoxib

  • Diclofenac

  • Diflunisal

  • Etodolac

  • Fenoprofen

  • Flurbiprofen

  • Ibuprofen

  • Indomethacin

  • Ketoprofen

  • Ketorolac

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Nabumetone

  • Naproxen

  • Nepafenac

  • Oxaprozin

  • Piroxicam

  • Salsalate

  • Sulindac

  • Tolmetin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of irbesartan. Make sure you tell your doctor if you have any other medical problems, especially:


  • Congestive heart failure, severe—Lowering of blood pressure by irbesartan may make this condition worse

  • Dehydration—Blood pressure–lowering effects of irbesartan may be increased.

  • Kidney disease—Effects of irbesartan may be increased because of slower removal of medicine from the body.

Proper Use of irbesartan


Take irbesartan only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. irbesartan works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same time each day.


Dosing


The dose of irbesartan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of irbesartan. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults and adolescents over 13 years of age—150 milligrams (mg) once a day. Your doctor may increase your dose if needed.

      • Children 6 to 12 years of age—75 mg once a day. Your doctor may increase your dose if needed.

      • Children under 6 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of irbesartan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using irbesartan


It is important that your doctor check your progress at regular visits to make sure that irbesartan is working properly and to check for unwanted effects.


Check with your doctor immediately if you think that you may be pregnant. Irbesartan may cause birth defects or other problems in the baby if taken during pregnancy.


Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.


Dizziness or light-headedness may occur, especially if you have been taking a diuretic (water pill). Make sure you know how you react to irbesartan before you drive, use machines, or do anything else that could be dangerous if you experience these effects.


Check with your doctor right away if you become sick while taking irbesartan, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.


Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.


irbesartan Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Rare
  • Dizziness, lightheadedness, or fainting

Frequency not determined

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Anxiety and/or nervousness

  • cold-like symptoms

  • belching, heartburn, and stomach discomfort

  • cold symptoms

  • diarrhea

  • headache

  • muscle or bone pain

  • unusual tiredness

  • Confusion, irregular heartbeat, numbness or tingling in hands, feet, or lips, shortness of breath, difficult breathing , or weakness or heaviness of legs

  • clay-colored stools, dark urine, itching, loss of appetite, stomach pain, or yellow eyes or skin

  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet or sex organs

Frequency not determined
  • Hives or welts, itching, redness of skin, or skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: irbesartan side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More irbesartan resources


  • Irbesartan Side Effects (in more detail)
  • Irbesartan Dosage
  • Irbesartan Use in Pregnancy & Breastfeeding
  • Irbesartan Drug Interactions
  • Irbesartan Support Group
  • 25 Reviews for Irbesartan - Add your own review/rating


  • Irbesartan Professional Patient Advice (Wolters Kluwer)

  • Irbesartan Monograph (AHFS DI)

  • Irbesartan MedFacts Consumer Leaflet (Wolters Kluwer)

  • Avapro Prescribing Information (FDA)

  • Avapro Consumer Overview



Compare irbesartan with other medications


  • Diabetic Kidney Disease
  • High Blood Pressure

Vaxib




Vaxib may be available in the countries listed below.


Ingredient matches for Vaxib



Valdecoxib

Valdecoxib is reported as an ingredient of Vaxib in the following countries:


  • Bangladesh

International Drug Name Search

Wednesday, 21 September 2016

Theraflu Nighttime Severe Cough and Cold Powder Packet


Pronunciation: a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin
Generic Name: Acetaminophen/Diphenhydramine/Phenylephrine
Brand Name: Theraflu Nighttime Severe Cough and Cold


Theraflu Nighttime Severe Cough and Cold Powder Packet is used for:

Relieving symptoms such as cough, fever, pain, sinus congestion and irritation, runny nose, sneezing, and itchy, watery eyes due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.


Theraflu Nighttime Severe Cough and Cold Powder Packet is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain and fever. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.


Do NOT use Theraflu Nighttime Severe Cough and Cold Powder Packet if:


  • you are allergic to any ingredient in Theraflu Nighttime Severe Cough and Cold Powder Packet

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you are unable to urinate or are having an asthma attack

  • you take sodium oxybate (GHB) or you have taken furazolidone, droxidopa, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

  • you use other medicines containing diphenhydramine, including those used on the skin or acetaminophen

Contact your doctor or health care provider right away if any of these apply to you.



Before using Theraflu Nighttime Severe Cough and Cold Powder Packet:


Some medical conditions may interact with Theraflu Nighttime Severe Cough and Cold Powder Packet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, plan to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of heart problems; blood vessel problems; high blood pressure; stroke; or fast, slow, or irregular heartbeat

  • if you have a history of blockage of your stomach, bladder, or intestines; asthma; lung problems (eg, chronic bronchitis, emphysema); trouble breathing when you sleep (apnea); ulcers; trouble urinating; or an enlarged prostate or other prostate problems

  • if you have a history of severe kidney problems, liver problems (eg, hepatitis), adrenal gland problems (eg, adrenal gland tumor), diabetes, glaucoma, seizures, the blood disease porphyria, an overactive thyroid, or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Theraflu Nighttime Severe Cough and Cold Powder Packet. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Catechol-o-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Theraflu Nighttime Severe Cough and Cold Powder Packet's side effects

  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of bleeding, irregular heartbeat, or heart attack may be increased

  • Beta-blockers (eg, propranolol), bromocriptine, or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Theraflu Nighttime Severe Cough and Cold Powder Packet

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Theraflu Nighttime Severe Cough and Cold Powder Packet

This may not be a complete list of all interactions that may occur. Ask your health care provider if Theraflu Nighttime Severe Cough and Cold Powder Packet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Theraflu Nighttime Severe Cough and Cold Powder Packet:


Use Theraflu Nighttime Severe Cough and Cold Powder Packet as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Theraflu Nighttime Severe Cough and Cold Powder Packet by mouth with or without food.

  • To prepare Theraflu Nighttime Severe Cough and Cold Powder Packet, place the contents of one packet in a glass (8 oz/240 mL) of hot water and allow the powder to dissolve completely.

  • To prepare using a microwave, add the powder from one packet to a glass (8 oz/240 mL) of cold water, stir briskly, and then heat. Stir contents again after heating, making sure the powder has dissolved completely. Do not overheat.

  • Sip the liquid over 10 to 15 minutes while it is warm. Rinse the container with an additional small amount of water and drink the contents to ensure the entire dose is taken.

  • If you miss a dose of Theraflu Nighttime Severe Cough and Cold Powder Packet and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Theraflu Nighttime Severe Cough and Cold Powder Packet.



Important safety information:


  • Theraflu Nighttime Severe Cough and Cold Powder Packet may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Theraflu Nighttime Severe Cough and Cold Powder Packet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Theraflu Nighttime Severe Cough and Cold Powder Packet; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do not take diet or appetite control medicines while you are taking Theraflu Nighttime Severe Cough and Cold Powder Packet without checking with your doctor.

  • Theraflu Nighttime Severe Cough and Cold Powder Packet has acetaminophen, diphenhydramine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has these or similar medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

  • Do NOT take more than the recommended dose without checking with your doctor.

  • Do not use Theraflu Nighttime Severe Cough and Cold Powder Packet for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • If your symptoms do not get better in 7 days or if they get worse, check with your doctor.

  • If you have a fever that becomes worse or lasts for more than 3 days, contact your doctor.

  • Contact your doctor if you have a sore throat that becomes severe, last for more than 2 days, or occurs with fever, headache, rash, nausea, or vomiting.

  • Theraflu Nighttime Severe Cough and Cold Powder Packet may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Theraflu Nighttime Severe Cough and Cold Powder Packet. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Theraflu Nighttime Severe Cough and Cold Powder Packet may harm your liver. Your risk may be greater if you drink alcohol while you are using Theraflu Nighttime Severe Cough and Cold Powder Packet or if you use more than 6 packets in 24 hours. Talk to your doctor before you take Theraflu Nighttime Severe Cough and Cold Powder Packet or other fever reducers if you drink more than 3 drinks with alcohol per day.

  • Theraflu Nighttime Severe Cough and Cold Powder Packet may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Theraflu Nighttime Severe Cough and Cold Powder Packet for a few days before the tests.

  • Tell your doctor or dentist that you take Theraflu Nighttime Severe Cough and Cold Powder Packet before you receive any medical or dental care, emergency care, or surgery.

  • Use Theraflu Nighttime Severe Cough and Cold Powder Packet with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Theraflu Nighttime Severe Cough and Cold Powder Packet in CHILDREN; they may be more sensitive to its effects, especially excitability.

  • Theraflu Nighttime Severe Cough and Cold Powder Packet should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Theraflu Nighttime Severe Cough and Cold Powder Packet while you are pregnant. Theraflu Nighttime Severe Cough and Cold Powder Packet is found in breast milk. Do not breast-feed while taking Theraflu Nighttime Severe Cough and Cold Powder Packet.


Possible side effects of Theraflu Nighttime Severe Cough and Cold Powder Packet:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; pale stools; seizures; severe drowsiness; severe or persistent dizziness, nervousness, lightheadedness, or headache; severe or persistent trouble sleeping; stomach pain; tremor; vision changes; yellowing of skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Theraflu Nighttime Severe Cough and Cold side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Theraflu Nighttime Severe Cough and Cold Powder Packet:

Store Theraflu Nighttime Severe Cough and Cold Powder Packet at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Theraflu Nighttime Severe Cough and Cold Powder Packet out of the reach of children and away from pets.


General information:


  • If you have any questions about Theraflu Nighttime Severe Cough and Cold Powder Packet, please talk with your doctor, pharmacist, or other health care provider.

  • Theraflu Nighttime Severe Cough and Cold Powder Packet is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Theraflu Nighttime Severe Cough and Cold Powder Packet. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Theraflu Nighttime Severe Cough and Cold resources


  • Theraflu Nighttime Severe Cough and Cold Side Effects (in more detail)
  • Theraflu Nighttime Severe Cough and Cold Use in Pregnancy & Breastfeeding
  • Theraflu Nighttime Severe Cough and Cold Drug Interactions
  • 0 Reviews for Theraflu Nighttime Severe Cough and Cold - Add your own review/rating


Compare Theraflu Nighttime Severe Cough and Cold with other medications


  • Cold Symptoms

digoxin immune FAB


Generic Name: digoxin immune FAB (di JOX in im MYOON FAB)

Brand Names: Digibind, DigiFab


What is digoxin immune FAB?

Digoxin immune FAB is used as an antidote to treat a life-threatening overdose of digoxin or digitoxin.


Digoxin immune FAB is not for treating a mild digitalis overdose.


Digoxin immune FAB may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about digoxin immune FAB?


If possible, before you receive digoxin immune FAB, tell your doctor if you have heart disease or kidney disease, or if you are allergic to antibiotics or papaya extracts such as papain or chymopapain.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you received this medication.


After treatment with digoxin immune FAB, you will be watched to make sure the medication has been effective and you no longer have any effects of the digitalis overdose.


What should I discuss with my health care provider before receiving digoxin immune FAB?


If possible, before you receive digoxin immune FAB, tell your doctor if you have:

  • heart disease;




  • kidney disease;




  • if you are allergic to antibiotics; or




  • if you are allergic to papaya extracts such as papain or chymopapain (Chymodiactin).




FDA pregnancy category C. Digoxin immune FAB may be harmful to an unborn baby. Tell your doctor if you are pregnant before receiving this medication. It is not known whether digoxin immune FAB passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In a poisoning situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with digoxin immune FAB. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.


How is digoxin immune FAB given?


Digoxin immune FAB is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting. The medicine must be given slowly through an IV infusion, and each dose can take up to 30 minutes to complete.


To be sure this medication is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. This will help your doctor determine how long to treat you with digoxin immune FAB.


This medication can cause you to have unusual results with certain digitalis tests. Tell any doctor who treats you that you have been treated with digoxin immune FAB.


What happens if I miss a dose?


Since digoxin immune FAB is given in an emergency situation by a healthcare professional, it is not likely that you will miss a dose.


What happens if I overdose?


An overdose of this medication is unlikely since it is given by a healthcare provider.


What should I avoid after receiving digoxin immune FAB?


Follow your doctor's instructions about any restrictions on food, beverages, or activity after you are treated with digoxin immune FAB.


Digoxin immune FAB side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

  • fever;




  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);




  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);




  • feeling short of breath, even with mild exertion; or




  • swelling, rapid weight gain.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Digoxin immune FAB Dosing Information


Usual Adult Dose for Digitalis Glycoside Toxicity:

Unknown amount of ingestion: 800 mg IV infusion if acute ingestion, 240 mg IV infusion if chronic ingestion.

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Dosing based on Serum Level:
Digoxin: Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).
Digitoxin: Dose (in # of vials) = (Serum digitoxin level in ng/mL) x (weight in kg) / (1000).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.

Usual Pediatric Dose for Digitalis Glycoside Toxicity:

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Children less than or equal to 20 kg: Dilution of reconstituted vial to 1 mg/mL may be desirable for doses of 3 mg or less.
Dose ( in # of mg) = Dose (in # vials) x 38 mg/vial.
Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection. The vial may be reconstituted and administered undiluted using a tuberculin syringe in infants and small children requiring small doses.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.


What other drugs will affect digoxin immune FAB?


This list is not complete and there may be other drugs that can interact with digoxin immune FAB. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More digoxin immune FAB resources


  • Digoxin immune FAB Side Effects (in more detail)
  • Digoxin immune FAB Use in Pregnancy & Breastfeeding
  • Digoxin immune FAB Drug Interactions
  • Digoxin immune FAB Support Group
  • 0 Reviews for Digoxin immune FAB - Add your own review/rating


  • Digibind Prescribing Information (FDA)

  • Digifab Prescribing Information (FDA)

  • Digoxin Immune Fab MedFacts Consumer Leaflet (Wolters Kluwer)



Compare digoxin immune FAB with other medications


  • Digitalis Glycoside Toxicity


Where can I get more information?


  • Your doctor or pharmacist can provide more information about digoxin immune FAB.

See also: digoxin immune FAB side effects (in more detail)


Prenessa




Prenessa may be available in the countries listed below.


Ingredient matches for Prenessa



Perindopril

Perindopril is reported as an ingredient of Prenessa in the following countries:


  • Czech Republic

  • Poland

  • Slovenia

Perindopril erbumine (a derivative of Perindopril) is reported as an ingredient of Prenessa in the following countries:


  • Croatia (Hrvatska)

  • Estonia

  • Hungary

  • Latvia

  • Lithuania

  • Poland

  • Slovakia

International Drug Name Search

Zeridame SR Prolonged Release Tablets 200mg





1. Name Of The Medicinal Product



Zeridame SR 200mg Prolonged Release Tablets


2. Qualitative And Quantitative Composition



One prolonged-release tablet contains 200mg tramadol hydrochloride.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Prolonged-release tablet.



Zeridame SR 200mg Prolonged Release Tablets are off white, capsule shaped tablets 17.1 mm long.



4. Clinical Particulars



4.1 Therapeutic Indications



Treatment of moderate to severe pain.



4.2 Posology And Method Of Administration



Route of Administration



Oral use



Posology



The dose should be adjusted to the severity of the pain and the individual clinical response of the patient.



For doses not realisable / practicable with this medicinal product, other strengths of this medicinal product are available.



Unless otherwise prescribed, Zeridame SR Prolonged Release Tablets should be given as follows:



Adults and adolescents older than 12 years:



The usual initial dose is 100mg, twice daily, in the morning and evening.



Dependent upon the needs of the patient, subsequent doses may be administered earlier than 12 hours, but must not be administered earlier than 8 hours after the previous dose. Under no circumstances should more than two doses be taken in any one 24 hour period.



If the painkilling is insufficient, the dose may be increased to:



150mg, twice daily or



200mg, twice daily.



Zeridame SR Prolonged Release Tablets should be swallowed completely, without breaking or chewing, independent of meals, with sufficient liquid.



The smallest effective analgesic dose should always be used. Daily doses of 400 mg of active substance must not be exceeded, unless exceptional medical reasons require so.



Under no circumstances should Zeridame SR be used for longer than absolutely necessary.



If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary.



Children



Zeridame SR is not suitable for children under the age of 12 years.



Elderly



As a rule adjustment of the dose, in elderly patients (up to 75 years) without any clinical manifestations of hepatic or renal impairment, is not necessary.



In elderly patients (over 75 years) elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.



Renal impairment, dialysis and hepatic impairment



In patients with serious renal or hepatic impairment the use of Zeridame SR is not recommended. In moderate cases, an adjustment of the dosage interval may be considered.



4.3 Contraindications



Zeridame SR Prolonged Release Tablets must not be used in:



- hypersensitivity to tramadol hydrochloride, or to any of the excipients in the medicinal product (see section 6.1),



- in acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs.





- in patients with epilepsy not adequately controlled by treatment



Zeridame SR Prolonged Release Tablets should not be used for opioid withdrawal treatment.



4.4 Special Warnings And Precautions For Use



Zeridame SR should only be used following a strict benefit – risk evaluation and appropriate precautionary measures in the following cases: in patients dependent on opioids, patients suffering head injuries, shock, decreased level of consciousness of unknown origin, disturbances of the respiratory centre or function, or increased intracranial pressure, patients with moderate to severe impaired liver or kidney function.



Zeridame SR should not be used in combination with alcohol.



In patients sensitive for opioids the medicine should be used cautiously.



Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit (400 mg).



The risk on convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold. (see section 4.5). Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons.



Tramadol has a low dependence potential. On long-term use tolerance, psychic and physical dependence may develop. In patients with a tendency to drug abuse or dependence, treatment should be for short periods under strict medical supervision.



Tramadol is not a suitable substitute in opioid dependent patients. The product does not suppress morphine withdrawal symptoms although it is an opioid agonist.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Tramadol / MAO – inhibitors



Zeridame SR should not be combined with MAO



Tramadol / Other centrally acting active substances



In concomitant use of Zeridame SR and other centrally acting drugs, including alcohol, a potentiation of CNS effects should be taken into consideration (See section 4.8).



Tramadol / Enzyme inhibitor / inducer



The results of pharmacokinetic research, so far, showed that no interactions need to be expected in concomitant or prior use of cimetidine (enzyme inhibitor).



The concomitant or prior use of carbamazepine (enzyme inducer) may reduce the analgesic effectiveness and shorten the duration of the action.



Tramadol / Mixed opioid agonists / antagonists



The combination of mixed agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) and tramadol is not recommended because it is theoretically possible that the analgesic effect of a pure agonist is attenuated under these circumstances.



Tramadol / Seizure threshold lowering drugs



Tramadol may induce convulsions and may increase the potential for selective serotonin re-uptake inhibitors, tricyclic antidepressants, anti-psychotics and other seizure threshold lowering drugs to cause convulsions.



Tramadol / Serotonergic agents



Isolated cases of serotonergic syndrome have been reported with the therapeutic use of tramadol in combination with other serotonergic agents such as selective serotonin re-uptake inhibitors (SSRIs). Serotonergic syndrome can be manifested by symptoms such as confusion, restlessness, fever, sweating, ataxia, hyperreflexia, myoclonia and diarrhoea. Withdrawal of the serotonergic agent produces a rapid improvement. It depends on the nature and severity of symptoms whether medicinal treatment is to be considered.



Tramadol / Coumarin derivatives



Caution should be exercised during concomitant treatment with tramadol and coumarin derivatives (e.g. warfarin) due to reports of increased INR and ecchymoses in some patients.



Tramadol / CYP3A4 Inhibitors



Other medicinal products with a known inhibiting effect on CYP3A4, such as ketoconazole and erythromycin, could inhibit the metabolism of tramadol (N-demethylation) and probably also the metabolism of the active O-demethyl-metabolite. The clinical relevancy of this interaction has not been investigated. (See section 4.8).



Tramadol / Ondansetron



In a limited number of studies the pre – or postoperative application of the antiemetic 5 – HT3 antagonist ondansetron increased the requirement of tramadol in patients with postoperative pain.



4.6 Pregnancy And Lactation



Animal tests with very large concentrations of tramadol showed effects on the development of the organs, bone formation and mortality of the neonate.



Teratogenic effects have not been found. Tramadol crosses the placenta, insufficient experience is available on the chronic use of tramadol during pregnancy. The repeated administration of tramadol during pregnancy can lead to increased tolerance of tramadol in the foetus and consequently to withdrawal symptoms in the new borne infant after birth, as a consequence of habituation.



Therefore Zeridame SR should not be used during pregnancy.



Tramadol – administered before or during birth – does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant.



When breastfeeding about 0.1 % of the tramadol dose administered is excreted in milk. Administration of Zeridame SR is not advised while breastfeeding.



In case of a once only administration of tramadol it is usually not required to discontinue breastfeeding.



4.7 Effects On Ability To Drive And Use Machines



Zeridame SR has minor or moderate influence on the ability to drive and use machines. It may cause drowsiness and blurred vision. This is especially applicable in combination with other psychotropic drugs, and alcohol. Ambulant patients should be warned not to drive or operate machinery if affected.



4.8 Undesirable Effects



The most commonly reported adverse drug reactions are nausea and dizziness, both occurring in > 1 / 10 of patients, very common.



Cardiovascular disorders:



Uncommon (> 1 / 1000 to 1 / 100): effects on cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse). These adverse effects may occur especially on intravenous administration and in patients who are physically stressed.



Rare (> 1 / 10000 to < 1 / 1000): bradycardia, increase in blood pressure.



Nervous system disorders:



Very common (> 1 / 10): dizziness



Common (> 1 / 100 to < 1 / 10): headache, drowsiness



Rare (>1 / 10000 to < 1 / 1000): changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle contractions, and syncope.



If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly (see section 4.5) respiratory depression may occur.



Epileptiform convulsions occurred mainly after administration of high doses of tramadol or after concomitant treatment with drugs, which can lower the seizure threshold or themselves induce cerebral convulsions (see section 4.4 and section 4.5)



Psychiatric disorders:



Rare (> 1 / 10000 to < 1 / 1000): hallucinations, confusion, anxiety, sleep distubances and nightmares. Psychic side-effects may vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders).



Dependence, abuse and addiction may occur.



Eye disorders:



Rare (> 1 / 10000 to < 1 / 1000): blurred vision



Respiratory disorders:



Worsening of asthma has also been reported, though a causal relationship has not been established.



Gastrointestinal disorders:



Very common (> 1 / 10): nausea



Common (> 1 / 100 to < 1 / 10): vomiting, constipation, dry mouth.



Uncommon (> 1 / 1000 to < 1 / 100): Retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating).



Skin and subcutaneous tissue disorders:



Common (> 1 / 100 to < 1 / 10): sweating



Uncommon (> 1 / 1000 to < 1 / 100): dermal reactions (e.g. pruritus, rash, urticaria)



Musculoskeletal disorders:



Rare (> 1 / 10000 to < 1 / 1000): motorial weakness



Hepato-biliary disorders:



Very rare (< 1 / 10000) an increase in liver enzyme values has been reported after use of tramadol.



Renal and urinary system disorders:



Rare (> 1 / 10000 to < 1 / 1000): micturition disorders (difficulty in passing urine and urinary retention).



Immune system disorders:



Rare (> 1 / 10000 to < 1 / 1000): Allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis;



General disorders:



Common (> 1 / 100 to < 1 / 10): fatigue.



Physical Dependence



Dependence, abuse, addiction, and withdrawal reactions may occur. Symptoms which occur on withdrawal, identical to withdrawal symptoms in opioids, may be: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastro intestinal symptoms. Very rare (< 1 / 10000) atypical withdrawal symptoms have been reported: panic attack, severe anxiety, hallucinations, paraesthesia, tinnitus, and other unusual central nervous system symptoms.



4.9 Overdose



Symptoms



In tramadol intoxication, in principle, the same symptoms occur as for all other central acting analgesics (opioids). In particular, these include miosis, vomiting, cardiovascular collapse, narrowing of consciousness leading to coma, convulsions, respiratory depression leading to respiratory failure.



Treatment



General emergency measures are applicable.



Maintenance of the airway (aspiration), maintenance of respiration and cardiovascular circulation depending on the symptoms.



Emptying of the stomach by means of vomiting (patient to be conscious) or by means of pumping the stomach. Consideration should also be given to the administration of activated charcoal, if necessary via the stomach pump tube. Depending how long has elapsed from ingestion, administration of a suitable laxative to speed up elimination should be considered. In the event that the patient's conciousness is reduced, intubation prior to performing these procedures is essential.



The antidote for respiratory depression is naloxone.



In animal tests naloxone proved to be ineffective against convulsions.



In that case diazepam should be administered intravenously.



Tramadol is only minimally removed from plasma using haemodialysis, haemofiltration or haemoperfusion.



Therefore treatment of acute overdose of tramadol using haemodialysis or haemofiltration alone is not a suitable way of detoxification. Administration of a suitable laxative may help to speed up elimination of unabsorbed tramadol, if administered early after overdose.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC code N 02 AX 02: Pharmacotherapeutic group: Analgesics, other opioids



Tramadol is a centrally acting opioid analgesic.



It is a non-selective, partial agonist of µ-, δ- and κ



Tramadol has an antitussive action.



Contrary to morphine tramadol does not suppress respiration in analgetic doses over a large range.



The action on the cardiovascular system is minimal.



The potency of tramadol is reported to be 1 / 10 to 1 / 6 of morphine.



5.2 Pharmacokinetic Properties



More than 90% of tramadol is absorbed after oral administration.



The mean absolute bioavailability is approximately 70 %, irrespective of concomitant intake of food.



The difference between absorbed and non – metabolised available tramadol is probably due to low first – pass effect. The first pass – effect after oral administration is a maximum of 30 %.



Tramadol has a high tissue affinity (Vd,β = 203 ± 40 l). Protein binding is about 20 %.



After administration of Minular 100 mg SR Tablets the maximum peak plasma concentration Cmax 141 ± 40 ng / ml is reached after 4.9 hours. After administration of Minular 200 mg SR Tablets a Cmax 260 ± 62 ng / ml is reached after 4.8 hours.



Tramadol passes the blood – brain and placenta barrier. Very small amounts of the substance and its O – demethyl derivative are found in the breast – milk (0.1 % and 0.02 % respectively of the applied dose).



Elimination of half-life t½β is approximately 6 h, irrespective of the mode of administration. In patients above 75 years of age it may be prolonged by a factor of 1.4.



In humans tramadol is mainly metabolised by means of N – and O – demethylation and conjugation of the O – demethylation products with glucuronic acid. Only O – desmethyltramadol is pharmacologically active. There are considerable interindividual quantitative differences between the other metabolites. So far, eleven metabolites have been found in the urine. Animal experiments have shown that O – desmethyltramadol is more potent than the parent substance by the factor 2 – 4. Its half life t½β (6 healthy volunteers) is 7.9 h (range 5.4 – 9.6 h) and is approximately that of tramadol.



The inhibition of one or both cytochrome p450 isoenzymes, cyp3a4 and cyp2d6 involved in the metabolism of tramadol, may affect the plasma concentration of tramadol or its active metabolite. The clinical consequences of any such interactions are not known.



Tramadol and its metabolites are almost completely excreted via the kidneys. Cumulative urinary excretion is 90 % of the total radioactivity of the administered dose. In cases of impaired hepatic and renal function the half – life may be slightly prolonged. In patients with cirrhosis of the liver, elimination half – lives of 13.3 ± 4.9 h (tramadol) and 18.5 ± 9.4 h (O – desmethyltramadol), in an extreme case 22.3 h and 36 h respectively have been determined. In patients with renal insufficiency (creatinine clearance < 5 ml / min) the values were 11 ± 3.2 h and 16.9 ± 3 h, in an extreme case 19.5 h and 43.2 h, respectively.



Tramadol has a linear pharmacokinetic profile within the therapeutic dosage range.



The relationship between serum concentrations and the analgesic effect is dose – dependent, but varies considerably in isolated cases. A serum concentration of 100 – 300 ng / ml is usually effective.



5.3 Preclinical Safety Data



In repeated oral and parenteral administration of tramadol during 6 to 26 weeks to rats and dogs, as also during 12 months to dogs, there are no indications for changes caused by the substance in haematological, clinical – chemical and histological experiments.



Only after high doses, far above the therapeutic doses, central symptoms occurred: restlessness, salivation, convulsion, reduced increase in weight.



Rats and dogs tolerate the oral dose of 20 mg / kg resp 10 mg / kg bodyweight, dogs also tolerate 20 mg / kg bodyweight, rectally administered.



Tramadol doses as from 50 mg / kg / day cause intoxication of the mother, in rats, and result in an increased mortality in newborn rats.



In young rats development disorders occurred as ossification disturbances, delayed opening of the vagina and eyes.



The fertility of male rats was not influenced.



However the percentage of females with young reduced after high dosages (as of 50 mg / kg / day).



In rabbits, toxic effects occurred as of 125 mg / kg in the mother and skeletal anomalies in the offspring.



In some in – vitro test systems there is report on mutagenic effects.



In in – vivo experiments there was no indication for mutagenic effects.



On the basis of the knowledge available up till now it is unclear whether tramadol possesses mutagenic potential.



Experiments have been performed on rats and mice with regard to the tumuorigenic potential of tramadol.



From tests in rats it could not be shown that the substance increases the chance of tumours.



In tests in mice an increased incidence of liver – cell adenomas in males (depending on the dose, with an insignificant increase as of 15 mg / kg) and an increased chance of lung tumours in females in all dose selections (significant, but not dose dependent) was found.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Calcium hydrogen phosphate dihydrate (E341),



Hydroxypropylcellulose (E463),



Colloidal anhydrous silica (E551),



Magnesium stearate (E470b).



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



3 years



PP / PE tablet container: 6 months after opening



6.4 Special Precautions For Storage



Store in the original package in order to protect from moisture.



6.5 Nature And Contents Of Container



Al / clear PVC blisters in carton boxes in packs of 10, 20, 30, 50, 60, 90, 100, 120, 180, and 500 tablets.



Al / opaque PVC child resistant blisters in carton boxes in packs of 10, 20, 30, 50, 60, 90, 100, 120, 180, and 500 tablets.



Polypropylene tablet container with polyethylene tamper evident closure containing 10, 20, 30, 50, 60, 90, 100, 120, 180, and 500 tablets.



Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



Any unused product or waste material should be disposed of in accordance with local requirements.



7. Marketing Authorisation Holder



Actavis Group hf



Reykjavíkurvegur 76-78



220 Hafnarfjordur



Iceland



8. Marketing Authorisation Number(S)



PL 21231/0015



9. Date Of First Authorisation/Renewal Of The Authorisation



10/08/2007



10. Date Of Revision Of The Text



10/08/2007